This application relates to the field of medicine, and more specifically involves corrective measures to improve the success of intraosseous medication injections in Dentistry and related fields requiring anaesthesia.
The art of deadening pain for the Dental industry was greatly improved by the discovery that smaller and more effective dosages of medication could be introduced beneath the cortical plate. Pivotally, U.S. Pat. No. 5,173,050 by Dillon in 1992 cited methods of and implements for drilling an initial perforation, thus allowing the dentist to remove the drill and re-enter the passageway with a hypodermic needle to deliver anaesthesia.
However, difficulties as taught by Dillon mainly involving failures of re-entry caused the industry to respond with two U.S. Pat. No 5,762,639 by Gibbs, and U.S. Pat. No. 5,779,708 by Wu, both describing methods to leave an intraosseous channel in place subsequent to drilling. This channel served as a guidance system to allow re-entry for medicative purposes.
Adversely, the necessity of hollow guidance sleeves to themselves be drills increased the expense over Dillon and introduced dangers involving incidents of breakage of the tiny-diameter, hollow implements. The threat of the breakage and subsequent successful retrieval of all foreign objects from the patient is complicated by the presence as taught by Gibbs and Wu of other separate and intricate inner plugging stylets or rods. These latter implements strengthen the overall shaft and block the backflow of bone chips and other organic matter while drilling. Also the health of the patient is subsequently put at risk by the open channel, which in some cases puts bacteria in open contact with the tissues beneath the bone for several hours.
Thus the introduction of bacteria from the air or contaminated water lines, the post recovery after inevitable failure of some instruments, and the more complicated nature of drill construction has dampened the success of the latter two patents. Because of the simplicity of the concept and the fact the Dillon apparatus allows the flesh around the perforation to seal the wound when no drill or needle is present, the commercial success and availability of this patent has flourished under the marketing name of the Stabident system. But the original complaint of difficult re-enty (for the Stabident system and other related prior art teaching such as the Villette injector) remains as a drawback for optimized delivery of medication.
Another pertinent negative to all three patents mentioned is the fact breakage of the drill or apparatus is prone to happen flush to the cortical plate. This is because the drill is hand held and success is dependent on the ability of the Dentist to maintain the angle of entry while penetrating the hard surface to reach the interior cancellous bone tissue. The patient may waver, the Dentist may move improperly, or the fabricating material may fail. The ability to retrieve the broken material is thus a serious issue.
It is therefore accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate heralded by radio-opaque markers to enable the checking of the positioning of the contemplated penetration at the time of X-rays, lessening the danger of having to drill a second entry, and/or inflicting damage to an unsuspected curved root.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate while simultaneously providing a precise anchoring device for X-ray film or devices, especially those of digital imagery where the sensor is thicker than the older models.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate to enable the angle of entry through the bone to be maintained as the penetrating drill passes through the bone, lessening the danger of breakage.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate to enable successful re-entry of the orifice by aligning the medicating needle tip back to the correct location, lessening trauma to the gingiva.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate to enable the angle of entry through the bone to be maintained as the medicating needle is subsequently inserted through the bone, lessening the danger of breakage.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate to provide a short protruding stem to grasp and remove should breakage of the drill, needle, or delivery device occur, lessening the danger of drills, needles, or delivery devices being broken flush to the cortical plate and slightly beneath the gingiva.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate to provide a precise predetermined angle of entry such as 29 degrees to the perpendicular, increasing success in the rear molar regions.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate while providing a visual aid herein termed a whisker to assist the dentist in maintaining a precise predetermined angle of entry such as 29 degrees to the perpendicular, decreasing incidents of breakage in the rear molar regions.
It is further accordingly an object of the present invention to provide a guidance channel exterior to the cortical plate that does not maintain a channel for airborne or waterborne bacteria to enter the underlying tissues.
These and many other objects and advantages will be readily apparent to one skilled in the art to which the invention pertains from a perusal of the claims and the following detailed description of preferred embodiments when read in conjunction with the appended drawings.
The placement of a guidance platform exterior to, but flush against, the cortical plate allows a selection of pre-formed entry points. These entry points are optimally near a small amount of semi (or fully) radio-opaque material. A Dentist can then position the platform at the best assumed position, and perform an X-ray of the subject tooth as usual, but have the alignment holes appear on the X-ray film as small circles or markers and confirm the position. Otherwise as is sometimes the case in intraosseous drilling, a crowded, curved, or deformed root may be struck with subsequent unwarranted damage to the ligaments or to the tooth itself, exposing it to infection. The drilling port chosen after the X-ray can be highlighted by the presence of color coding introduced by the Dentist on the surface of the guidance platform by a magic marker type implement.
The contact side of the platform may be slightly beveled to reflect the natural curvature of the gingiva covering the cortical plate.
The multiple holes of the guidance platform can be angled with some at right angles and some slanted. A typical slanted example for molars would be 29 degrees up from the perpendicular, which is the same as 61 degrees from the plane of the surface of the cortical plate. Although frontal teeth may be reached with ease, the rear teeth usually require the Dentist to come at the bone off the perpendicular due to the inner cheeks of the patient. Also, in actual practice the correct placement of the drill between the molars diminishes the more to the rear the desired location is.
A short tubule of soft plastic termed a whisker is contemplated to rise from the guidance platform at the angle of the guidance port. This gives a Dentist a visual reference to initially and subsequently hold the drilling apparatus at the correct angle to match the desired angle known to produce the best results. Thus the whisker tubule takes the guess work out of holding a drill or needle at the best angle relative to the cortical plate.
The guidance platform itself may be attached to prior art apparatus such as a RINN positioner, rubber dam, or X-ray bite blocks if subsequent re-entry to the hole is not required after the initial injection of medication. However, a dedicated method of attachment to a customized bite-block or two-component polycarbon such as polyvinyl, through a vertically adjustable connector would be better. The subsequent ability of an indexed system to accurately reposition the guidance platform eliminates the probing and searching associated with the Stabident and other nonguided systems when the pain is returning and the patient needs more nerve deadening. This is true especially in the extremely posterior positions on the lingual (or tongue) side where the Dentist may have to otherwise search for the tiny hole with a mirror.
The ability of the indexed guidance platform to be accurately reinserted into the mouth eliminates the problem, and once again allows immediate access. The indexing may be achieved by having the patient bite down on a wedge of impressionable material such as medical grade Styrofoam tailored to that purpose. Alternately, fast hardening two-component impression material such as medical grade polyvinyls may be placed while viscous over both a tooth and plastic inserts termed strap runners. These polyvinyls are available in clear uncolored varieties and are designed to receive the bite and create the indexed surface within a forty second set time. Since the strap runners are a suitable containment medium and are embedded in the polyvinyl, this system can be used in lieu of a bite block and is the preferred embodiment due to the superior indexing. With either system, bite block or polyvinyl, the inner lingual side can connect to a clothes-pin type connector or the like to fasten an X-ray film along the inside of the subject tooth.
As a third style of embodiment more useful for root canal procedures, a clamped anchoring system that fastens to the base of the tooth is contemplated to be left in place in the mouth for the duration of the visit, with the guidance platform left in place underneath a rubber dam which can be peeled back at will. Alternately in cases where its presence may impede the Dentist, the guidance platform may be snapped out from its locking mechanism or flipped out of position in such a manner that it can be returned to service as required.
These dedicated embodiments also allow a better accommodation to the much thicker sensor plate of digital imagery X-rays. Current methods of alignment are not typically done with an indexed system, which often defeats the precise placement the expensive digital imagery requires.
The guidance platform is connected to the anchoring system by a precise clamp for systems using prior art devices such as a RINN positioner, or in dedicated systems by a molded plastic arm that before installation curls the platform inward. By pulling the platform outward by hand or with small clamps and having the patient bite down on the indexing block, the platform can then be released to be carried snugly inward against the gingiva by the gentle force of the plastic arm returning to its natural curvature.
Also the up or down height of the platform can be adjusted by the use of a trombone lock or the like, which allows the Dentist to choose and then set in place the optimum vertical location of the drilling port relative to the jawbone. This adjustment covers the variance between adult or children, and is regulated by pulling back the wedge of the trombone lock out of its notch, sliding the plastic arm up or down, and releasing the wedge back into another underlying notch.
The physical presence of the guidance platform directly against the gingiva in almost all cases ensures that if a break of the drill or needle occurs, after removal of the guidance platform there will be an elevated stub protruding that is easily grasped and retrieved. This is a tremendous assist to the Dentist and avoids possible trauma and/or surgery to the patient to remove buried implements in or beyond the cortical plate.